Senior Associate, Pharmacovigilance - Serbia/UK - Remote

• Author Safety Management Plan for assigned studies
• Attend internal and client meetings as appropriate, Attend and present at Investigator Meetings
• Review incoming SAE data for completeness and accuracy
• Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information
• Generate queries for missing or unclear information and follow-up with sites for resolution
• Perform QC of SAEs processed by other PV Associates
• Generate regulatory reports and perform safety submissions as needed
• Prepare and submit periodic safety reports as needed

Zahtevi

Potrebne kvalifikacije

Tehničke veštine

Excellent understanding of medical and scientific terminology

Excellent understanding of computer technology, and management of relational database systems, including extraction of data

Iskustvo

Minimum of 5 years of pharmacovigilance experience (pre-approval clinical trials)

Demonstrated ability to handle multiple competing priorities while adhering to applicable timelines

Ability to work independently, prioritize work effectively and work successfully in matrix team environment

Obrazovanje

Bachelor’s degree in a science-related field, or nursing, or equivalent

Meke veštine

Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment

Excellent organization skills and ability to handle multiple competing priorities within tight timelines

Consistently demonstrates commitment, dependability, cooperation, adaptability and flexibility in executing daily tasks and responsibilities

Ability to anticipate needs and follow through on all assigned tasks

Able to work well independently, but also able to seek input effectively from others when appropriate

Makes sound decisions within the scope of responsibility

Focuses on solutions and problem resolution verses complaining or placing blame